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Traditional Chinese medicine formula granules are made of traditional Chinese medicine decoction pieces conforming to processing specifications as raw materials, referring to traditional decoction methods, according to the different characteristics of various medicinal materials, and using modern production techniques and technologies to extract, concentrate, dry, and prepare all ingredients of single-flavor decoction pieces.
It is a single-flavor Chinese medicine granule that can be directly formulated by doctors
.
In recent years, with the widespread application of traditional Chinese medicine formula particles, both the country and the locality have been accelerating its larger-scale opening up
.
For example, on October 21, the Jiangsu Provincial Food and Drug Administration issued the "Rules for the Administration of Traditional Chinese Medicine Formula Granules in Jiangsu Province
.
" It is clearly stated in the rules that pharmaceutical manufacturers are responsible for the production and quality assurance of traditional Chinese medicine formula granules; pharmaceutical manufacturers should log in to the "Chinese medicine formula granule registration management module of the drug business application system of the State Drug Administration" (hereinafter referred to as the Chinese medicine formula granule registration platform), In accordance with relevant regulations, upload relevant materials on the record platform of Chinese medicine formula granules; production should also be carried out in accordance with the record production process and drug standards
.
It is understood that since February this year, four departments including the State Food and Drug Administration and the National Medical Insurance Administration issued the "Announcement on Ending the Pilot Work of Chinese Medicine Formula Granules" (referred to as the "Announcement")
.
Ended the 20-year pilot work of traditional Chinese medicine formula granules, so that all Chinese medicine companies can produce traditional Chinese medicine formula granules.
The filing system is no longer required.
At present, except for Jiangsu Province, Guizhou, Jiangsu, Shaanxi, Yunnan, Guangdong and other provinces They have also successively issued the working procedures for formulating the quality standards of traditional Chinese medicine formula granules and the requirements for application materials, and are actively implementing the accelerated and standardized development of the traditional Chinese medicine formula granules industry
.
On September 7, the Hebei Provincial Drug Administration took the lead in drafting the "Rules for the Implementation of the Management of Traditional Chinese Medicine Granules in Hebei Province" (draft for comments)
.
Among them, specific requirements are put forward for many aspects such as production management, use management, drug standards, and filing
.
On the same day, the Drug Administration of Ningxia Hui Autonomous Region also issued a notice on publicly soliciting opinions on the "Rules for the Management of Traditional Chinese Medicine Formula Granules in Ningxia Hui Autonomous Region (Trial) (Draft for Solicitation of Comments)"
.
The draft for comments includes seven chapters and 27 articles, and multiple measures are taken to strengthen the filing and supervision of Chinese medicine formula granules..
The industry believes that under the influence of the state's continuous progress in the construction of relevant standards for traditional Chinese medicine formula granules, and the influence of various provincial drug supervision departments in stepping up the formulation and release of relevant standards for traditional Chinese medicine formula granules, the market space for traditional Chinese medicine formula granules will become more and more competitive in the future.
It will also become more and more intense
.
In this context, for companies that want to share the blue ocean of the Chinese medicine formula granule market, whether they have been in the industry for many years, or are just entering or preparing to enter the market, they need to fulfill the main responsibility and responsibility of the whole life cycle of the drug.
Relevant obligations are to strictly regulate the production, management, and sales of traditional Chinese medicine formula granules; at the same time, it is also necessary to prepare for the production capacity and production scale in order to better promote the high-quality and healthy development of the industry
.